(Sr.) Document Control Manager
San Francisco, CA
Operations – Quality /
Full Time /
Hybrid
About Pendulum
Pendulum® is on a mission to help people improve physical and mental health by creating a new category of products that target the microbiome. We are researching, developing and commercializing a novel class of rationally-designed Live Synbiotics™ (probiotics + prebiotics) that have demonstrated clinical efficacy to treat conditions like metabolic syndrome, inflammation and neurodegeneration.
Pendulum has created proprietary pipelines to build a unique discovery platform that identifies key, novel bacterial strains and the prebiotics that feed them.
We are a highly collaborative team of scientists, engineers, physicians, marketers and salespeople interested in improving human health by using the latest research from diverse fields, such as microbiology, molecular biology, high-throughput genomics, distributed computing, pharmaceutical development and nutrition. We believe strongly in an individual’s transparency and strong communication to enable the most effective and efficient path to team success.
If you’re interested in building a new category of products that will help improve the lives of people globally and you love working in a cross-functional, collaborative, inspiring environment, please continue reading!
Position Summary:
We are seeking a (Senior) Quality Documentation Manager to oversee the electronic Quality Management System (eQMS) and the Documentation Control program. This person will adhere to the company’s document and SOP’s procedures while ensuring their accuracy, quality, and integrity. The Quality Documentation Specialist is responsible for the creation, implementation, and revision of new and existing GMP batch production records, supplier qualification documentation, and SOP’s. This position reports to the Quality Director and partners with cross functional team members to ensure compliance and operational success through user focused documentation.
This includes document control responsibility spanning the Supply Chain network including our CMO’s for fill and finish. We’re looking for an exceptional and experienced documentation manager who has outstanding organizational skills, good attention to detail, and can coordinate efforts to address multiple priorities. We’re also looking for someone who thrives in a fast-paced, lean and collaborative environment. They should be both passionate and comfortable working with a very young brand in its early stages of growth.
What You'll Do:
- Be the Quality Department’s primary owner of the Documentation Control policy and procedures.
- Review and approve of the master batch record templates and technical specifications.
- Develop appropriate disposition metrics, work with manufacturing personnel to achieve said targets. Generate and report on Quality and Continuous Improvement metrics on agreed frequency.
- Create training materials for subject matter input. Provide training to Operations team
- Organize and coordinate vendor and CMO qualification records for management review.
- Develops strategies and documents for cleaning and process validation of analytical equipment and products in compliance with site SOPs and regulatory guidance.
- Own quality records (change control, CAPA’s, deviations) and deliver to timelines established.
- Lead root cause investigations related to performance trends and formal deviations. Autonomously lead and manage projects to implement continuous improvement opportunities.
- Manage process for drafting and implementing manufacturing protocols and temporary changes in manufacturing.
- Performs weekly quality reviews of eQMSl database by assuring new documents have been entered using appropriate protocols.
Knowledge Requirements:
- Bachelor’s degree in a technical field (chemistry, microbiology, food science, biochemistry, chemical engineering, or related discipline) from an accredited college/university.
- Minimum (6) year documentation experience and three (3) years related food industry or biotech industry experience. Preference will be given to candidates with experience in probiotics or dietary supplement manufacturing.
- Familiarity with FSMA, SQF, and 21 CFR part 117 and/or 111 requirements; PCQI (Preventive Controls Qualified Individual) preferred
- Excellent communication skills, drive, and sense of urgency
- Solid organizational and time management skills are required to prioritize activities in a manner consistent with departmental and site wide objectives. Must have the ability to work as a self-starter and handle multiple priorities in a dynamic cross-functional team-based environment.
- Knowledge and experience writing, revising and creating cGMP records and SOP’s.
- Hands-on experience facilitating problem solving and root cause investigations in a cGMP environment - Develops, implements, and assesses solutions for complex problems.
- Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
- Knowledge of statistical packages is a plus
- 3 day office hybrid, full time onsite preferred
Salary & Benefits
- $118,380 - $151,250
- Medical, Dental, and Vision
- Commuter Benefits
- Life & STD Insurance
- Company match on 401 (k)
- Flexible Time Off (FTO)
- Equity
Pendulum Therapeutics, Inc. is committed to creating a diverse environment and is proud to be an equal
opportunity employer. All qualified applicants will receive consideration for employment without regard to
race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics,
disability, age, or veteran status. We welcome all to apply.
